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Leadership and Process in Medical Writing
Session Chair(s)
Robin Whitsell
President
Whitsell Innovations, Inc., United States
Medical writers frequently perform their roles with little authority over their teams despite high-stakes outcomes. They understand the needs of their target audiences (clinical study teams, busy health authority reviewers, and internal stakeholders) and have to create consensus and cohesion. Frequently, medical writers turn to metrics and best practices to inform the best pathway forward. This symposium will detail how to incorporate processes and leadership to streamline the document generation process and bolster the effectiveness of medical writing teams. The presenters will focus discussion around three areas: creation of high quality protocols through data-driven metrics, planning and implementing effective comment-resolution meetings, and formation of accountable teams.
Learning Objective : Identify key approaches to create rigorously designed protocols; Acquire techniques to focus teams on the issues that matter; Detail the creation of effective and vested teams.
Speaker(s)
He Who Cares Most Loses? How to Develop Team Ownership with Medical Writing
Robin Whitsell
Whitsell Innovations, Inc., United States
President
Improving Quality and Reducing Risk through Data-Driven Protocol Design and Review
David Gemzik
Clinical Ink, United States
Vice President, Product Management
Make Every Comment Resolution Meeting Worth Your Team’s Time
Steve Sibley, MS
Certara, United States
Vice President, Global Submissions and Submissions Leadership